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| ID | Type | Description | Link |
|---|---|---|---|
| UAB | Other Identifier | UAB |
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This study looks at a treatment called transcutaneous auricular vagus nerve stimulation, or taVNS. taVNS uses a small device worn on the ear to gently stimulate a nerve. Researchers want to find out if this treatment is safe and well-tolerated for people who recently had a spinal cord injury (SCI).
This study will also help researchers learn whether taVNS can be safely added to standard mobility therapy, and whether it might help improve mobility.
This study has two main goals:
This study has two parts.
In the first part, participants will wear the taVNS device once for a short period of time. During this part investigators will measure how participant's heart rate and blood pressure may change before, during, and after the stimulation. Investigators will also ask about how the stimulation made participants feel.
In the second part, participants will wear the taVNS device for a short time right before a mobility therapy session. During this part investigators will measure how participants heart rate and blood pressure may change before, during, and after the stimulation and during and after the walking therapy. Investigators will also ask about how the stimulation made participants feel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| taVNS application | Experimental | This is a single arm study with two Phases. In Phase 1 taVNS will be applied bilaterally for a brief period while the individual is in inpatient rehabilitation In Phase 2 taVNS will be applied for a brief period immediately before each mobility therapy session while the period is in inpatient rehabilitation. The mobility therapy sessions are routine care. Frequency and intensity of these sessions are determined by the therapists. All individuals must complete Phase 1 before starting Phase 2. Not all individuals who complete Phase 1 will be eligible for Phase 2. Please see eligibility criteria for more details. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transauricular vagus nerve stimulation | Device | bilateral transauricular vagal nerve stimulation |
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| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 Hypotension Symptoms Immediately before taVNS is applied | Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible | Immediately before Phase 1 taVNS application |
| Phase 1 Hypotension Symptoms during taVNS spplication | Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible | During application of Phase 1 taVNS |
| Phase 1 Hypotension Symptoms Immediately after taVNS is stopped | Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible | Immediately after Phase 1 taVNS is stopped |
| Phase 1 Hypotension Symptoms 5 minutes after taVNS is stopped | Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible | 5 minutes after Phase 1 taVNS is stopped |
| Phase 1 taVNS Tolerability survey | 10 question survey addressing perceived sensation, tolerability, side effects, and open text response | Within 48 hours of competing Phase 1 taVNS |
| Phase 2 taVNS Tolerability survey | 10 question survey addressing perceived sensation, tolerability, side effects, and open text response | Within 48 hours of completing Phase 2 taVNS |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 Blood Pressure Immediately before taVNS is applied | Systolic and Diastolic Blood Pressure (mmHg) | Immediately before taVNS Phase 1 application is applied |
| Phase 1 Blood Pressure during taVNS application |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel E Cowan, PhD | Contact | 2059345034 | recowan@uabmc.edu | |
| Christopher Williamson, MBA | Contact | 2059343776 | cmwilliamson@uabmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rachel E Cowan, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
This is an internally funded study with limited personnel support. Adequate preparation of the data to ensure seamless and rigorous sharing cannot be guaranteed at the time of registration. The investigators may update the plan to share IPD in the future if additional personnel support becomes available.
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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Systolic and Diastolic Blood Pressure (mmHg)
| During taVNS Phase 1 application |
| Phase 1 Blood Pressure Immediately after taVNS is stopped | Systolic and Diastolic Blood Pressure (mmHg) | Immediately after taVNS Phase 1 application is stopped |
| Phase 1 Blood Pressure 5 minutes after taVNS is stopped | Systolic and Diastolic Blood Pressure (mmHg) | 5 minutes after taVNS Phase 1 application is stopped |
| Phase 2 IRF-PAI Section GG Total Mobility Score Rehabilitation Admission | Total score on the IRF-PAI Section GG mobility. Scores range from 15 to 90. Extracted from the medical record | Admission to rehabilitation |
| Phase 2 IRF-PAI Section GG Total Mobility Score Rehabilitation Discharge | Total score on the IRF-PAI Section GG mobility. Scores range from 15 to 90. Extracted from the medical record | Immediately after discharge from rehabilitation |
| D014947 | Wounds and Injuries |